Comparing superabsorbent dressings for venous leg ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the clinical performance of two commonly used CE-marked superabsorbent dressings in managing venous leg ulcers (VLUs). It focuses on assessing the absorption capacity of these dressings and their effectiveness in preventing skin maceration and leakage. Participants will be monitored for their wound healing progress while using the assigned dressing in routine care. The study will include individuals with VLUs that meet specific size and duration criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
2. Participant is mentally and physically able to participate in this study
3. Men, women, diverse ≥ 18 years
4. Participant complies with study visit schedule
5. Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
6. Participant suffers from lower leg ulcer\* (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following:
7. Ulcer is not younger than 4 weeks and not older than 1 year
8. Ulcer is ranging between 2 cm2 and 800 cm2
9. One side of the ulcer is not extending 40 cm
10. Depth of ulcer \< 2 cm
11. Ankle-brachial pressure index (ABPI) of \>0.8 and ≤1.3, measurement not older than 12 months \* Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the study.

Exclusion Criteria:

1. Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
2. Participant is expected not to be willing or able to follow the study outlines and requirements
3. Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
4. Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
5. Participant uses any medication that could potentially delay the wound healing ability
6. Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc.
7. Participant is pregnant or currently breastfeeding
8. Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone

8\. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone 9. Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days 10. Participant with a history of sensitivity to any of the components of the study product 11. Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant 12. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 13. The ulcer has exposed bone, tendon, ligaments and/or joint 14. History of radiation at the study ulcer site 15. Participant's lesion is a primary skin cancer 16. Participant's lesion is the manifestation of a metastasis

Where it's running

• Niels Stensen Klinik, Christliches-Klinikum-Melle
  Melle, Niedersachsten, Germany Recruiting
• Mid Yorkshire Teaching NHS Trust Pinderfields Hospital
  Wakefield, West Yorkshire, United Kingdom Recruiting
• Northumbria Healthcare NHS Foundation Trust
  Ashington, United Kingdom Recruiting

Study contacts

• Study coordinator: Hardy Schweigel, PhD
• Email: hardy.schweigel@essity.com
• Phone: +491522

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.